Sertraline: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Sertraline. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Headache | 25% |
| Nausea | 25% |
| Insomnia | 21% |
| Diarrhea/loose stools | 20% |
| Ejaculation failure (1) | 14% |
| Mouth dry | 14% |
| Somnolence | 13% |
| Dizziness | 12% |
| Fatigue | 12% |
| Tremor | 8% |
| Dyspepsia | 8% |
| Sweating increased | 7% |
| Anorexia | 6% |
| Constipation | 6% |
| Libido decreased | 6% |
| Decreased libido** | 6% |
| Agitation | 5% |
| Nervousness | 5% |
| Vomiting | 4% |
| Anxiety | 4% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Major Depressive Disorder – Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8…
Medical disclaimer: Always consult a qualified healthcare professional about any medication.